MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	G34309
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Initially this event was considered not reportable however after investigation if has become clear that the device cannot be ruled out as a contributing factor, similar event have been reported that has led to serious injury.Therefore, the event is considered reportable from 04dec2025.Summary of investigational findings: when pressing the release button, the celect-pt filter would not release from the jugular introducer.The filter was re-sheathed and after removal the filter was released on the tabletop.Another filter was successfully placed.The complaint reported by the user was confirmed.The complaint is confirmed based on customer and/or sales representative testimony.A part of the device was returned for evaluation.The device evaluation determined the following: the jugular introducer was returned and the grasping hook was found according to specifications, but the release mechanism stuck in hardened blood/contrast.However, the blockage is considered a consequence of the processing time and as the filter was not returned, the exact reason for the difficulties encountered during attempt to release the filter from the jugular introducer cannot be determined.A review of the manufacturing records and/or specifications did not reveal any discrepancies/nonconformances that could have contributed to this complaint issue.The investigation concludes the complaint device was manufactured to specification.There is no evidence to suggest that the user did not follow the instructions for use and/or label.A definitive cause could not be determined from the investigation.Possible causes are rotation of preloaded filter inside the sheath, the release button was not completely pushed, or excessive tension during deployment.An internal action is not deemed necessary at this time.Trending will monitor if any future actions are required.After considering this event the risk associated with the use of this device is still deemed adequate.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Description of event according to initial reporter: a patient of undisclosed gender and age underwent an unknown procedure in which the cook celect platinum navalign jugular vena cava filter set, g34309, was used.Device was prepped per protocol.Filter would not release from hook upon pressing blue button.Re-sheathed filter and removed from the sheath.Deployed filter on tabletop.Opened new filter and was able to deploy that fine.Patient outcome: no additional procedures necessary.No harm to patient.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DK 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DK 4632
• Manufacturer Contact: louise baekmand ; sandet 6; bjaeverskov 4632 ; DK 4632 ; 56868382
• MDR Report Key: 23765994
• Report Number: 3002808486-2025-00254
• Device Sequence Number: 21263117
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)280129(10)E4658886
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K233680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E4658886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown